BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2831792 · Received November 9, 2012

    Report

    Report Number
    2183996-2012-01688
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 28, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT REPORTED HER BLOOD GLUCOSE MONITOR INDICATED THAT IT WAS NOT ABLE TO COMMUNICATE WITH THE INFUSION DEVICE. AT 11:47 AM, THE PT'S BLOOD GLUCOSE WAS 368 MG/DL. HER NORMAL BLOOD GLUCOSE LEVEL IS LESS THAN 200 MG/DL. SHE ATTEMPTED A BOLUS OF 25 UNITS OF INSULIN, BUT THE BLOOD GLUCOSE MONITOR AGAIN INDICATED WAS UNABLE TO COMMUNICATE WITH THE INFUSION DEVICE. THE PT REQUIRED ASSISTANCE TREATING HER ELEVATED BLOOD GLUCOSE LEVEL BECAUSE, SHE WAS DIZZY AND VISION WAS BLURRED PREVENTING HER FROM BEING ABLE TO READ THE DISPLAY ON THE BLOOD GLUCOSE MONITOR. AT 11:49 AM, THE PT'S HUSBAND PROGRAMMED A BOLUS OF 25 UNITS OF INSULIN ON HER INFUSION DEVICE. AT 11:51PM, HER BLOOD GLUCOSE LEVEL WAS 451 MG/DL. AT 12:36AM, THE PT'S BLOOD GLUCOSE LEVEL WAS 308 MG/DL AND SHE WAS BEGINNING TO FEEL BETTER. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP